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Two drugs, KRT-232 and a tyrosine kinase inhibitor (TKI), to treat chronic myeloid leukemia (CML) that has come back (relapsed) or has not gotten better with treatment (refractory)

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18 and older

Phase 1, Phase 2

5 Locations

NCT04835584

Clinical Trial Goal


To find out if the combination of KRT-232 and a TKI is safe and works well to treat CML that has relapsed or is refractory

You may be able to join this trial if you:


  • Are 18 years old or older
  • Have CML that has relapsed or is refractory
  • Do not have cancer cells with T315I mutation. Your doctor can tell you this 
  • Agree to have other standard tests done to see if you can be in the clinical trial 

Trial Details


Dasatinib and nilotinib are TKIs that block BCR-ABL in certain cells.
KRT-232 is a small molecule inhibitor that blocks MDM2 in certain cells.
 
You’ll get treatment in cycles that last a month. In each cycle, you'll get: 
  • KRT-232 – Given as a pill that you take by mouth 1 time each day for 7 days
  • Dasatinib or nilotinib – Given as a pill that you take by mouth. The dose you'll get depends on what your doctors think is best for your health 

You may continue treatment for as long as the clinical trial doctors think it’s best for your health. You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for up to 4 years.

The Food and Drug Administration (FDA) has approved dasatinib and nilotinib to treat CML. The FDA has not yet approved KRT-232.

Contacts


John Mei, 650-542-0136, jmei@kartosthera.com

Locations

University of Alabama BirminghamRECRUITING

Birmingham, Alabama

Georgia Cancer Center at Augusta UniversityRECRUITING

Augusta, Georgia

University of Pittsburgh Medical CenterRECRUITING

Pittsburgh, Pennsylvania

Texas Oncology- Sammons CC at BaylorRECRUITING

Dallas, Texas

Medical College of WisconsinRECRUITING

Milwaukee, Wisconsin

ClinicalTrials.gov record


NCT04835584. First posted on 4/8/21

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